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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVATEC SPA REEF CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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INVATEC SPA REEF CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNK-CV-GWY-SBI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 08/21/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure, a medtronic standard pta balloon was used to treat the anastomosis. Approximately 12 months post index procedure, restenosis within the juxta-anastomosis region in the avf was reported. The anastomosis was treated with a non-medtronic pta on the same day. The investigator assessed the event as not related to the index device, procedure or paclitaxel medication. Sponsor assessed the event as not related to the index device, procedure or paclitaxel medication. The patient recovered.
 
Manufacturer Narrative
The medtronic device used during the index procedure was a reef balloon. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameREEF
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
MDR Report Key7938310
MDR Text Key122846064
Report Number3004066202-2018-00048
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CV-GWY-SBI
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/05/2018 Patient Sequence Number: 1
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